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510(k) K902481

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER by Gambro, Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
June 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)
  • K890111 — GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER (February 8, 1989)

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  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
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  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)